Events

Recall of Device Recall Arrowgard Blue and Arrowgard Blue

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Arrow International Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    67833
  • Event Risk Class
    Class 2
  • Event Number
    Z-1633-2014
  • Event Initiated Date
    2013-07-17
  • Event Date Posted
    2014-05-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-03-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=126459
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Catheter,intravascular,therapeutic,short-term less than 30 days - Product Code FOZ
  • Reason
    The labeling states that the kit contains introducer needle: echogenic 18 ga. x 2.5 (6.35cm) xtw and 5ml arrow raulerson spring-wire introduction syringe; however, the kit contains, and should state, introducer needle: 18 ga. x 2.5 (6.35cm) xtw and 5ml arrow raulerson spring-wire introduction syringe. as a result of this labeling inconsistency, if the clinician were to place the needle under x-r.
  • Action
    Arrow sent an Urgent Medical Device Recall Notification letter dated July 17, 2013, was sent to the customer requesting they discontinue use and quarantine any remaining affected product for return to Arrow. Our records indicate that you have received products that are subject to this voluntary recall. We are now asking that you take the following actions: 1. If you have affected stock, immediately discontinue use and quarantine any products with the product and lot numbers listed above. 2. To return product, complete the enclosed Recall Acknowledgement Form and fax it to 1-800-343-2935, Attn: Customer Service. This will allow us to document the amount of product you have on hand for return. Your sales representative will contact you with a Return Goods Authorization (RGA) Number and will provide instructions and assistance for the return of product to Arrow International. 3. If you have no affected stock, please complete the enclosed Recall Acknowledgment Form and fax it to 1-800-343-2935, Attn: Customer Service. This will allow us to document your receipt of this letter.

Device

Device Recall Arrowgard Blue and Arrowgard Blue
  • Model / Serial
    MF2016829 RM2072044 RM2034076 RM2095792 RM2056629 RM3015571 RM2069733
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Distribution only to MI.
  • Product Description
    Arrowgard Blue and Arrowgard Blue Plus Pressure Injectable Central Venous Catheter, a multiple-lumen catheter that permits venous access to central circulation. Catalog number ASK-45703-PHF.
  • Manufacturer
    Arrow International Inc

Manufacturer

Arrow International Inc
  • Manufacturer Address
    Arrow International Inc, 2400 Bernville Road, Reading PA 19605
  • Manufacturer Parent Company (2017)
    Teleflex Incorporated
  • Source
    USFDA